Song Tae Jun, Lee Jae Hoon, Lee Sang Soo, Jang Ji Woong, Kim Jung Wook, Ok Tae Jin, Oh Dong Wook, Park Do Hyun, Seo Dong Wan, Lee Sung Koo, Kim Myung-Hwan, Kim Song Cheol, Kim Chul Nam, Yun Sung Cheol
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.
Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD.
In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement.
Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755).
In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.).
术前胆道引流（PBD）并置入支架已常用于恶性胆道梗阻患者。在PBD中，与塑料支架相比，置入全覆膜自膨式金属支架（FCSEMS）可能具有更长的通畅时间和更低的胆管炎发生率。我们旨在评估哪种类型的支架在PBD中显示出更好的效果。
在这项多中心前瞻性随机试验中，我们于2012年1月至2014年12月期间，对86例恶性胆道梗阻患者比较了PBD采用FCSEMS与塑料支架的效果。梗阻性黄疸患者被随机分配接受PBD并置入塑料支架或FCSEMS。
两组的基线特征无显著差异。所有患者的内镜支架置入在技术上均获成功。两组的手术相关不良事件无显著差异（塑料支架组与FCSEMS组；16.3%对16.3%，P = 1.0）。塑料支架组16.3%的患者和FCSEMS组14.0%的患者需要再次干预（P = 0.763）。PBD后至手术的间隔时间（塑料支架组与FCSEMS组；14.2±8.3天对12.3±6.9天，P = 0.426）在两组间无显著差异。手术相关不良事件在塑料支架组发生于43.6%的患者，在FCSEMS组发生于40.0%的患者（P = 0.755）。
在可切除的恶性胆道梗阻患者中，PBD采用塑料支架和FCSEMS的效果相似。考虑到成本效益，PBD采用塑料支架可能优于置入FCSEMS。（临床试验注册号：NCT01789502。）
